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Related Experiment Videos

Deliquescence in binary mixtures.

Adnan K Salameh1, Lynne S Taylor

  • 1Industrial and Physical Pharmacy, School of Pharmacy, Purdue University, West Lafayette, Indiana 47907, USA.

Pharmaceutical Research
|March 24, 2005
PubMed
Summary

Binary mixtures of pharmaceutical ingredients and excipients are more hygroscopic, exhibiting lower critical relative humidity (RH0), than individual components. This finding is crucial for understanding drug product stability.

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Area of Science:

  • Physical Chemistry
  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Deliquescence is a critical phase transition for solid materials, particularly pharmaceuticals.
  • Understanding the factors influencing deliquescence is vital for drug formulation and stability.

Purpose of the Study:

  • To investigate the reduction in critical relative humidity (RH0) for binary solid mixtures of deliquescent active pharmaceutical ingredients (APIs) and excipients.
  • To compare experimental deliquescence data with predictions from the Ross equation.

Main Methods:

  • Gravimetric water vapor sorption balance used to measure RH0 for single components and binary mixtures.
  • Water activity (a(w)) of saturated solutions measured using a water activity meter.
  • Optical microscopy for visual observation; Ross equation for theoretical prediction.

Main Results:

  • Experimental RH0 values for mixtures closely matched saturated solution water activity (a(w)).
  • Binary mixtures consistently exhibited lower RH0 values than individual APIs or excipients.
  • Observed RH0mix values were generally higher than those predicted by the Ross equation.

Conclusions:

  • Deliquescent API-excipient mixtures demonstrate increased hygroscopicity (lower RH0) compared to their individual components.
  • This phenomenon has significant implications for the stability of active pharmaceutical ingredients and final drug products.

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